Another email from last night. Looks like breast cancer study is underway too!!
Here is a snippet from the email:
CVac: Apparently it works in other cancers?
Are any human trials under way or have there been any to date other than for Ovarian cancer? If not are any planned soon or will the company wait for phase 3 in ovarian to be complete?
If CVac works in Ovarian cancer and is FDA approved, will all future trials on other cancers go straight to phase 3?
"Prima BioMed, Ltd has no clinical data in other cancers beyond that reported from our first clinical study where one patient with a renal cell carcinoma had prolonged progression free survival. In theory, any tumour that overproduces mucin-1 is a target for Cvac ?. Other companies (for example Merck KGaA) are pursuing mucin-1 as a target for tumours such as non-small cell lung cancer, and indeed Merck are conducting a registration study, based on excellent phase II data for that indication. Our strategic approach was to attempt to treat a tumour with a high unmet medical need (ovarian cancer) where our research indicated that there were no other mucin-1 vaccines in clinical development. ?We have achieved orphan product status in the US and EU, allowing us free regulatory advice in Europe and reduced fees in the United States. As we have previously stated, we are looking at conducting a global study with Cvac? in patients with breast cancer and discussions on design of that study are underway. Other studies with Cvac?, once it has regulatory approval, would most probably be registration trials."
Another words if CVac gets the go ahead in Ovarian cancer it will go straight to Phase 3 for other cancers that have mucin-1.
Obvious risks with Prima are a clinical fail, however I believe we are all underestimating how big a player Prima Biomed could be in the oncology space.
Biotech is set to be the fastest growing industry over the next few years with oncology leading that growth. It doesn't get much better than PRR from an investment perspective!
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